Job Description:
Responsibilities:
Responsible for reviewing projects on a quarterly basis to ensure they are compliant from a pharmacovigilance, OEC and Finance perspective.
- Identify projects that have been closed
- Review to ensure the following
- Pharmacovigilance is marked appropriately
- OPI record is accurate & closed out
- Ensure all final documents are attached
- Final Deliverable
- Stimuli, Discussion and Questionnaire
- Invoices and that they add up to project total
- Honoraria is within FMV
- Honoraria is listed accurate in the invoice
- All country approvals are uploaded in the IF record
Work with the researchers to locate & upload missing documents
Report possible CAPA items to management
Work with Management to rectify CAPA's and keep documented records of CAPA's
Responsible for conducting Supplier IT Evaluation for new & existing suppliers
- Manage preferred supplier evaluations and ensure suppliers are compliant with company policies.
- Collaborate with US MABI to ensure we streamline process and continue communication for agility and to avoid redundancies.
- Engage suppliers when evaluation is required
- Schedule Evaluation
- Collect required Documents
- Conduct the interview
- Provide overview of policy and evaluation process
- Complete & submit required documents to pertinent departments for review and approval.
- Oversee the process and assist as necessary to ensure risk mitigations are completed in a timely manner.
- Send supplier information to Insight Farm support for upload.
- Send supplier information to finance for DSP entry.
Manage Trackers for the Immunology team
- JAK Tracker
- Add updated data from MySource for monthly Global tracking
- Competitive Launch Timing Trackers
- Manage/Update tracker to ensure stakeholders expectations and alignments are
- documented.
SAP/SRM
- Create Shopping Carts in SRM
- Ensure proper details are entered
- Attach pertinent documents for approval
- Keep electronic copies of each cart
- Inform stakeholders of status of approval
- Track PO's and document approvals
- Invoice Approval
- Send the invoice for approvals to correct stakeholder
Provide Stakeholder with pending Invoice & fully executed SOW for review
- Document Stakeholders response for Audit purposes in Electronic Folders
- Then process the payment on my end for supplier to receive payment for services provided
OPI-Stakeholders
- Maintain PV records of ongoing projects
- Ensure information is updated as appropriate as projects progress
- Work with affiliate(s) PV team to ensure projects are compliant
- Ensure Insight Farm projects are closed out accordingly and supplier project
- reconciliations have been completed and sent in to appropriate departments
Veeva/PromoMats
- Upload UK projects for country approvals
- Ensure all required documentation is submitted for approval
- Ensure that the actual document that is being reviewed has all country required
- footnotes (month/year submitted, PV/IF and PromoMat#)
- Work with UK reviewers and researchers to incorporate any necessary updates to
- documents
- Track and document approvals
Assist with BI/BA forum
- Manage contacts
- Assist in running the meetings
- Provide necessary information to affiliates when needed
Job Types: Full-time, Contract
Pay: $42.00 per hour
Expected hours: 40.00 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person